1. Scientific Evidence for Personalized Nutrition: Ethical Implications of Methodological Limitations
A. Cecile J.W. Janssens, PhD
Research Professor of Epidemiology
Department of Epidemiology
@cecilejanssens

2. Same presentation 10 years ago

3. Different companies, same issues …

4. Lack of scientific evidence

6. Not informing major risks still issue
Informing participants should also include impact of tested genes on other diseases
Commentary reports about two studies:
Testing APOE gene to tailor recommendations saturated fat intake
Forgot to disclose major risk of Alzheimer’s disease
Information: ethical issues around informed consent, privacy, and data sharing (not discussed today)

7. v

8. What professionals say: limited evidence
2014
2013
All still very premature

9. What companies claim

10. What their disclaimers reveal …

11. … and the Terms of Service
Allows applications to be of poor quality and lack scientific basis, and their recommendations to be irrelevant and totally wrong

12. Ethical principles Medicine Marketing (AMA) Autonomy Beneficence
Nonmaleficence
Justice
Ethical norms:
Do no harm
Foster trust in marketing
Embrace ethical values: Respect, Honesty, Responsibility, Transparency, Fairness, Citizenship

13. Beneficence Intent of doing good, includes
Developing and maintaining skills and knowledge, and continually update
Consider individual circumstances of all patients
Is commercial offer in interest of customers or company?
Insufficient evidence:
Many statistically significant gene-diet-outcome associations, some replicated
No studies that show how/whether diet can ‘compensate’ unfavorable genetic effects on diet

14. USPSTF Analytic Framework
Glucose test
Diet/exercise
Obese individuals
Pre-diabetes
Weight loss
Reduced diabetes, CVD, mortality
Figure taken from Melnyk et al. Pediatrics 2012;130:e399-e407

15. USPSTF Analytic Framework
DNA testing + survey + lab
Personalized nutrition
Healthy consumers
Personal profiles
???
Figure taken from Melnyk et al. Pediatrics 2012;130:e399-e407

16. Autonomy
Consumer should decide themselves whether testing is useful for them  personal utility
 Needs information to make informed decision
Yet,
Companies use proprietary algorithms to create personalized recommendations
Consumers and scientists have no insight in validity
Proprietary ‘algorithms’ suggest advanced processing of data, but may well hide lack of knowledge

17. Proprietary algorithms: how advanced?
Personalized diet
SNP with small effect Other lab/lifestyle …
SNP with small effect
Other lab/lifestyle …
Simple rule …
Recommendation …
Personalized combination

18. Companies may still do same as 10 years ago
Arkadianos et al Nutrition Journal 2007

19. Companies can be transparent about lack of scientific evidence, open about algorithms, and still have a market and a future

20. Onward Better and more relevant scientific studies
More respectful conversation with consumers
Genetically personalized nutrition recommendations is still premature, largely lacking appropriate scientific basis
Just say it
2005